September/October 2003
MX Magazine
Selected Contents
EDITOR'S PAGE
COVER STORY
Mission
Critical
Interview by Steve Halasey
FDA Commissioner
Mark B. McClellan looks at national healthcare policy and his agency’s pivotal role in promoting medtech innovation.
Sidebars: FDA's Medical Technology Initiative | McClellan: Cautious Optimist? BUSINESS
PLANNING & TECHNOLOGY DEVELOPMENT
Expanded
version of this article.
(You must be registered
with Medical DeviceLink to access the expanded version of this article.)
Optimizing
a Clinical Research Program
Cynthia Fink and Beth Silverstein
An early-stage company can save time and money if it develops a suitable
program.
Sidebars: Business
Issues That Affect Clinical Program Planning | Elements
of a Clinical Development Program | On-Line
Resources from FDA
Appraising
Complaint System Effectiveness
Mark Allen
An audit
that examines complaints deemed not worth investigating can expose system
weaknesses and improve compliance.
G
Health
Information Privacy and Security
Mark E. Lutes
The iron law of
unintended consequences strikes again.
Start Spreading the News?
Darren W. Alch and Deidre L. Shearer
Promising clinical trial developments may seem cause for crowing, but FDA and SEC could think otherwise.
Sidebar: Disclosure Management
Conflict ResolutionJames W. Heller
Mediation is a win-win alternative to adversarial litigation or arbitration. It doesn't hurt that it saves money, not to mention business relationships.
Sidebars: Self-Help | Connections
Expanded sidebars of this article.
(You must be registered with Medical DeviceLink to access the expanded version of this article.)
BUSINESS NEWS
- Top
Medtech Firms Post Strong 2Q Gains
Sidebar: Start-up Funding - FTC/DOJ Hearings to Focus on GPOs
- Zimmer Prevails in Bid to Acquire Centerpulse
- Device User Fees Skyrocket for FY04
